,,ii  #aah? ,,congress  #b;d ,session   
,s4 #eeag  ,,9 ,,! ,,s5ate ,,( ,,!      
,,unit$ ,,/ates  ,decemb] #ab1 #bjbd,mr4
 ,budd 7= himself & ,ms4 ,hassan7       
introduc$ ! foll[+ bill2 :i* 0 read     
twice & ref]r$ to ! ,committee on ,=eign
 ,relations  ,a ,,bill  ,to provide = ! 
e/abli%m5t1 )9 ! ,food & ,drug          
,adm9i/ration1 ( an ,abraham ,accords   
,(fice to promote & facilitate          
coop]ation betwe5 ! ,food & ,drug       
,adm9i/ration & entities 9 ,abraham     
,accords c\ntries wi%+ to "w ) ! ag5cy 9
 ord] to develop & sell products 9 !    
,unit$ ,/ates1 & = o!r purposes4  #a4   
,%ort title ,?is ,act may be cit$ z !   
,unit$ ,/ates-,abraham ,accords         
,coop]ation & ,security ,act ( #bjbd4   
#b4 ,e/abli%m5t ( ,abraham ,accords     
,(fice )9 ,food & ,drug ,adm9i/ration   
7a7 ,9 g5]al ,*apt] ,x ( ! ,f$]al ,food1
 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 
#cia et seq47 is am5d$ by add+ at ! end 
! foll[+3  #ajae4 ,abraham ,accords     
,(fice  7a7 ,9 g5]al ,! ,secret>y1 act+ 

?r\gh ! ,commission] ( ,food & ,drugs1  
%all e/abli% )9 ! ,food & ,drug         
,adm9i/ration an (fice1 to be kn[n z !  
,abraham ,accords ,(fice1 to be head$ by
 a director4  7b7 ,(fice ,n lat] ?an #b 
ye>s aft] ! date ( enactm5t ( ?is       
section1 ! ,secret>y %all-- 7#a7 9      
consultation ) ! gov]nm5ts ( ,abraham   
,accords c\ntries1 e/abli% ! ,abraham   
,accords ,(fice 9 an ,abraham ,accords  
c\ntry2 &  7#b7 assign to su* ,(fice su*
 p]sonnel ( ! ,food & ,drug             
,adm9i/ration z ! ,secret>y det]m9es    
necess>y to c>ry out ! functions ( !    
,(fice4  7c7 ,duties ,! ,secret>y1 act+ 
?r\gh ! ,director ( ! ,abraham ,accords 
,(fice1 %all1 n lat] ?an #cj days aft] !
 ,abraham ,accords ,(fice is e/abli%$-- 
7#a7 provide te*nical assi/ance to      
p>ties 9 ,abraham ,accords c\ntries on  
ov]sight ( good manufactur+ practices & 
o!r issues relevant to manufactur+      
m$ical products t are regulat$ by !     
,food & ,drug ,adm9i/ration2  7#b7      
facilitate int]actions betwe5 ! ,food & 

,drug ,adm9i/ration & int]e/$ p>ties 9  
,abraham ,accords c\ntries1 includ+ by  
%>+ relevant in=mation reg>d+ ,unit$    
,/ates regulatory pa?ways ) su* p>ties2 
7#c7 (f] te*nical assi/ance reg>d+      
rese>*1 developm5t1 & manufactur+ (     
drugs & devices to p>ties locat$ 9 an   
,abraham ,accords c\ntry t int5d to file
 an application = approval1 lic5sure1   
cle>ance1 or au?orization ( su* a drug  
or device "u section #eje1 #eaj7k71     
#eac7;f77#b71 or #eae ( ?is ,act or     
section #cea ( ! ,public ,heal? ,s]vice 
,act2 &  7#d7 c>ry out o!r functions &  
activities z ! ,secret>y det]m9es to be 
necess>y to c>ry out ?is section4  7d7  
,waiv] au?ority  7#a7 ,9 g5]al ,!       
,secret>y1 9 consultation ) ! ,secret>y 
( ,/ate1 may susp5d1 = a p]iod ( n m ?an
 #f mon?s1 ! application ( any ( !      
actions describ$ 9 subsection 7b7 or 7c7
 ) respect to an ,abraham ,accords      
c\ntry if ! ,secret>y det]m9es1 &       
reports to ! appropriate congressional  
committees1 t-- 7,a7 ! ex]cise ( su*    

waiv] au?ority w\ld fur!r ! purposes (  
?is section2 or  7,b7 su* a susp5sion is
 necess>y to protect ! national security
 int]e/s ( ! ,unit$ ,/ates4  7#b7       
,r5ewal ( waiv] ,! ,secret>y1 9         
consultation ) ! ,secret>y ( ,/ate1 may 
r5ew a waiv] "u p>agraph 7#a7 = an      
additional p]iod ( n m ?an #f mon?s1 n  
lat] ?an #ae days be=e ! initial waiv]  
expires1 if ! ,secret>y makes an        
additional det]m9ation & report describ$
 9 p>agraph 7#a74  7e7 ,def9ition ,9 ?is
 section1 ! t]m ,abraham ,accords c\ntry
 means a c\ntry id5tifi$ by ! ,dep>tm5t 
( ,/ate z hav+ sign$ ! ,abraham         
,accords4  7f7 ,sunset ,?is section %all
 cease to h =ce or effect on ! date t is
 #ab ye>s aft] ! date on :i* ! ,abraham 
,accords ,(fice is e/abli%$ "u          
subsection 7a74  4  7b7 ,report to      
,congress  7#a7 ,9 g5]al ,n lat] ?an #c 
ye>s aft] ! date ( enactm5t ( ?is ,act1 
! ,secret>y ( ,heal? & ,human ,s]vices  
%all submit to ! ,congress a report on !
 ,abraham ,accords ,(fice e/abli%$ "u   

section #ajae ( ! ,f$]al ,food1 ,drug1 &
 ,cosmetic ,act1 z add$ by subsection   
7a71 includ+-- 7,a7 an evaluation (--   
7i7 h[ su* ,(fice has made progress 9   
ensur+ t manufactur]s 9 ,abraham        
,accords c\ntries comply ) applicable   
requirem5ts ) respect to applications   
submitt$ = approval1 lic5sure1 cle>ance1
 or au?orization ( a drug or device "u  
section #eje1 #eaj7k71 #eac7;f77#b71 or 
#eae ( ! ,f$]al ,food1 ,drug1 &         
,cosmetic ,act 7#ba ,u4,s4,c4 #cee1     
#cfj7k71 #cfj;c7f77#b71 #cfj;e7 or      
section #cea ( ! ,public ,heal? ,s]vice 
,act 7#db ,u4,s4,c4 #bfb72 &  7ii7 a li/
 ( p>ties t su* ,(fice has assi/$       
pursuant to section #ajae7;c7 ( ! ,f$]al
 ,food1 ,drug1 & ,cosmetic ,act1 z add$ 
by subsection 7a71 & ! drugs & devices t
 su* p>ties int5d to be ! subjects ( an 
application describ$ 9 clause 7i72 &    
7,b7 recomm5dations = increas+ & improv+
 coord9ation betwe5 ! ,food & ,drug     
,adm9i/ration & entities 9 ,abraham     
,accords c\ntries4  7#b7 ,def9ition ,9  

?is section1 ! t]m ,abraham ,accords    
c\ntry has ! mean+ giv5 su* t]m 9       
section #ajae ( ! ,f$]al ,food1 ,drug1 &
 ,cosmetic ,act1 z add$ by subsection   
7a74